Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer (CULTURE3D)

Institut Curie

Status: Completed

Conditions: Colorectal Cancer

Treatments: Procedure: biopsy to obtain a chemogram

Study type: Interventional

Funder types: Other

Identifiers

NCT02849106

IC 2009-08

Details and patient eligibility

About

Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture 3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.

Full description

The CULTURE 3D study is a prospective, open labelled, multicenter trial. The aim is to evaluate the feasibility of ex vivo culture 3D (chemogram) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.

Patients will have biopsies in a metastasis or in the primitive tumor before treatment. The sample will be used for a 3D ex vivo cells culture. A chemogram will be made based on cells proliferation data (Ki67) and apoptosis (M30).

Results from this chemogram will not interfere with the treatment combination choice.

The treatment response will be evaluated by the RECIST assessment and will be then compared to the chemogram.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 years old or more
2. Colorectal cancer with synchronous or metachronous metastases
3. Metastasis and/or primitive tumor (in case of synchronous metastases) accessible to biopsy
4. Measurable metastatic disease (echography, CT and/or MRI, PET-FDG)
5. Indication for treatment with a combination including FOLFOX/FOLFIRI associated to an anti VEGF drug (Avastin)
6. No adjuvant chemotherapy for the primitive colorectal cancer and no line of chemotherapy for metastatic disease during the year prior to inclusion.
7. Life expectancy > 3 months (ECOG 0-1-2).
8. Informed and signed consent by the patient.

Exclusion criteria

1. Elevation of Carcinoembryonic antigen (CEA) without measurable metastatic disease
2. Medical contraindication to chemotherapy or biotherapy as FOLFOX/FOLFIRI or Avastin.
3. Treatment with FOLFOX/FOLFIRI and biotherapy anti-EGFR (epidermal growth factor receptor)(Erbitux) planned
4. Patient already enrolled in an other clinical trial with another first line of chemotherapy.
5. Pregnant women, breastfeeding or of childbearing age not taking contraceptive
6. Persons deprived of liberty.
7. Subject unable to make follow up schedule

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

biopsy to obtain a chemogram

Experimental group

Treatment:

Procedure: biopsy to obtain a chemogram